MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-31 for SKYTRON ELITE 6500 manufactured by Skytron.
[3991562]
Operating room bed failure. Bed controls did not work properly during surgical procedure. Unable to move bed from rotated position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034511 |
| MDR Report Key | 3632282 |
| Date Received | 2013-12-31 |
| Date of Report | 2013-12-27 |
| Date of Event | 2013-06-20 |
| Date Added to Maude | 2014-02-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | HOSPITAL BED |
| Product Code | BWN |
| Date Received | 2013-12-31 |
| Model Number | ELITE 6500 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYTRON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-31 |